N/A
N=327
Morbidity in Newly Diagnosed type2 Diabetes in Adults
Type2 Diabetes Mellitus · Complications
Bottom Line
View on ClinicalTrials.gov: NCT02002091 ↗Enrolled (actual)
327
Serious AEs
2.3%
Results posted
Sep 2018
Primary outcome: Primary: Number and Prevalence of Patients With Diabetic Retinopathy — 9; 18 Participants — p=0.706
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- no specific treatment (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- University of Algiers
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Prevalence of Patients With Diabetic Retinopathy |
9; 18 | 0.706 |
| PRIMARY Number of Patients With Distal Diabetic Neuropathy |
42; 56 | 0.346 |
| PRIMARY Number of Patients With Chronic Kidney Disease (CKD) |
35; 43 | 0.123 |
| PRIMARY Number of Patients With Hypertension |
82; 136 | 0.968 |
| PRIMARY Number of Patients With Silent Myocardial Ischemia |
11; 4 | 0.004 sig |
| PRIMARY Number of Patients With Lower Extremity Artery Disease |
6; 12 | 0.988 |
| PRIMARY Number of Patients With Carotid Artery Stenosis |
7; 3 | 0.038 sig |
| PRIMARY Number of Patients With Renal Artery Stenosis or Elevated Intrarenal Resistance Index |
2; 2 | — |
| PRIMARY Number of Patients With Cardiac Autonomic Neuropathy |
10; 19 | 0.917 |
| PRIMARY Number of Patients With Bladder Autonomic Neuropathy |
5; 11 | 0.816 |
| PRIMARY Number of Patients With Gastro-intestinal Autonomic Neuropathy |
0; 6 | 0.008 sig |
| PRIMARY Number of Patients With Erectile Dysfunction |
63 | — |
| SECONDARY Number of Patients With New Cardiac Events During Follow-up |
7; 2 | 0.025 sig |
| SECONDARY Number of Patients With New Stroke or Transient Ischemic Attack |
1; 2 | — |
| SECONDARY Number of Patients With Lower Limbs Atherothrombotic Accident |
0; 1 | — |
| SECONDARY Number of Patients That Died From Cardio Vascular Cause |
3; 2 | 0.059 |
Summary
* It is a prospective,observational, cohort study
* The main purpose of the study is to assess the prevalence of diabetic chronic complications in newly diagnosed type 2 diabetics in suburban area of Algiers.
* The secondary purpose is to study the impact of diabetic renal complications as a risk factor on the atherothrombotic events.
Eligibility Criteria
Inclusion Criteria
- Men or women aged from 40 to 70 years
- Newly diagnosed type 2 diabetes
- Never treated for diabetes
Exclusion Criteria
- Gestational diabetes
Data sourced from ClinicalTrials.gov (NCT02002091). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.